Label: GEHWOL FUSSKRAFT NAIL AND SKIN PROTECTION- clotrimazole spray 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/13

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  • Gehwol FUSSKRAFT Nail and Skin Protection Spray
  • Active ingredient

    Clotrimazole 0,4%

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  • Purpose

    Antifungal

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  • Uses

    • Effectively treats most athlete‘s foot

    • Cares for skin leaving it elastic and beautiful.

    • Gehwol Fusskraft Foot Spray with panthenol and vitamin E, helps improve elasticity and stablility of the skin.

    • Clotrimazol effectively treats most athlete‘s foot. The dosing valve distributes exactly the right quantity of oil between the toes.

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  • Warning

    For external use only.

    When using this product

    avoid contact with the eyes

    Stop use and ask a Doctor if

    • There is not improvement within 4 weeks.
    • Irritation occurs.

    Do not use on children

    Under 2 years of age unless directed by a Doctor.

    Keep out of reach of children

    if swallowed get medical help or contact a poison control center right away

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  • Directions

    • Shake can well before use.
    • Clean the affected area and dry thoroughly.
    • Spray a layer over the affected area twice daily (morning and night )
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  • Other Information

    Protect from sunlight and do not expose to temperatures exceeding 120°F (50° C)

    Do not pierce or burn, even after use. Do not spray on a naked flame or any incandescent material. Keep away from source of ignition-no smoking

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  • Inactive Ingredients

    Isobutane, Alcohol denat, Isopropyl Myristate, Octyldodecanol, PEG-40 Hydrogenated Castor Oil, Panthenol, Bisabolol, Aqua (Water), Parfum (Fragrance), Undecylenamide DEA, Tocopheryl Acetate, Propylene Glycol

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  • INGREDIENTS AND APPEARANCE
    GEHWOL FUSSKRAFT NAIL AND SKIN PROTECTION 
    clotrimazole spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:45264-008
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE 4 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ISOBUTANE  
    ALCOHOL  
    ISOPROPYL MYRISTATE  
    OCTYLDECANOL  
    CASTOR OIL  
    PANTHENOL  
    LEVOMENOL  
    UNDECYLENIC ACID  
    .ALPHA.-TOCOPHEROL ACETATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45264-008-50 50 mL in 1 BOTTLE, UNIT-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 06/18/2009
    Labeler - Eduard Gerlach GmbH (315343350)
    Registrant - Eduard Gerlach GmbH (315343350)
    Establishment
    Name Address ID/FEI Business Operations
    Eduard Gerlach GmbH 315343350 manufacture(45264-008)
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